A registration trial of the Intracranial Visualized stent in the treatment of wide-necked intracranial aneurysms
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Intracranial stent for wide-necked aneurysms
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGAdequate occlusion rate of aneurysms
The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Adequate occlusion rate includes Class I and Class II.
Time frame: Time Frame: 360±60 days
Complete occlusion rate of aneurysms
The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Complete occlusion rate includes Class I
Time frame: Time Frame: 360±30 days
Retreatment rate
Percentage of subjects who had aneurysm recurrence and underwent a secondary suergry during follow-up
Time frame: Time Frame: 360±30 days
Successful stent placement
Successful stent placement was defined as the stent was successfully released at the appropriate position, and covered the aneurysm's neck completely while the parent artery remained unobstructed postoperatively.
Time frame: Intraoperation
Incidence od in-stent stenosis (≥50%)
Time frame: Time Frame: 360±30 days
Incidence of device-relared stroke or death
Time frame: perioperative
Incidence of ipsilateral stroke of neurological death
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Time frame: Time Frame: 360±30 days
Incidence of device-related severe adverse event
Time frame: Time Frame: 360±30 days
Incidence of aneurysm rupture
Time frame: Time Frame: 360±30 days